Company: Akkodis Germany Tech Experts GmbH

Working time model: Full-time

Work location: Baden-Baden (DE)

Job description:

For one of our pharmaceutical clients in the Baden-Baden area, we are currently seeking a Senior Manager (m/f/d) for Regulatory Affairs, Quality & Dossier Management.

Client details:

Akkodis is a global digital engineering consultancy that connects technology and talent to accelerate transformation, drive innovation, and build a smarter future. With more than 50,000 experts in over 30 countries, we connect industries and technologies – from AI and data analytics to cloud, edge, automation, and cybersecurity.

Job Description

- Responsibility for the creation, review, updating, and strategic development of regulatory CMC documentation for national and international registration procedures, in particular CTD modules 2.3 and 3

- Coordination of the creation of regulatory documents and data packages in close collaboration with Regulatory Affairs, QA, Production, Analytics, and Development

- Independent creation, consolidation, and quality control of registration dossiers, including eCTD submissions, variations, and renewals

- Evaluation of regulatory requirements and development of registration strategies in the field of Chemistry, Manufacturing, and Controls (CMC)

- Handling complex national and international regulatory inquiries and preparing well-founded responses and scientific-regulatory justifications

- Monitoring of regulatory developments and evaluation of their impact on existing registrations and ongoing projects

- Leading and participating in projects to optimize regulatory processes, documentation standards, data governance, and eCTD compliance

- Providing expert advice to internal stakeholders on regulatory and CMC-related issues and supporting inspections and audits

Profile

- Completed degree in a natural science, e.g., chemical engineering, chemistry, or a related field B. Pharmacy, Chemistry, Biology or Biotechnology; PhD preferred

- Several years of professional experience in Regulatory Affairs CMC, Pharmaceutical Affairs or a comparable role in the pharmaceutical or GxP-regulated environment

- Sound knowledge of regulatory requirements (EU, national authorities, ICH) and experience with CTD/eCTD dossiers

- Proven experience in the preparation and evaluation of CMC documentation for CTD modules 2.3 and 3 as well as in variations, renewals and lifecycle management

- Proficient use of regulatory document management and publishing systems, e.g., eCTD Manager

- Strong analytical skills and high competence in evaluating complex pharmaceutical and regulatory issues

- Fluent German and English, both written and spoken

- Independent, structured, and solution-oriented work style, as well as strong communication and stakeholder management skills

The offer

- Diverse and varied topics in a modern, multicultural work environment

- Flexible working hours and the option to work remotely

- Company pension: 100% employer-funded retirement plan

- Company health insurance: Annual budget of €900, e.g., for vision aids, dental care

- Secure job in an attractive, growing pharmaceutical company

Content: © Federal Employment Agency − Reference number: 12634-BB-645266-7878-3412-S

Company: Akkodis Germany Tech Experts GmbH

Working time model: Full-time

Work location: Baden-Baden (DE)

Job description:

For one of our pharmaceutical clients in the Baden-Baden area, we are currently seeking a Senior Manager (m/f/d) for Regulatory Affairs, Quality & Dossier Management.

Client details:

Akkodis is a global digital engineering consultancy that connects technology and talent to accelerate transformation, drive innovation, and build a smarter future. With more than 50,000 experts in over 30 countries, we connect industries and technologies – from AI and data analytics to cloud, edge, automation, and cybersecurity.

Job Description

- Responsibility for the creation, review, updating, and strategic development of regulatory CMC documentation for national and international registration procedures, in particular CTD modules 2.3 and 3

- Coordination of the creation of regulatory documents and data packages in close collaboration with Regulatory Affairs, QA, Production, Analytics, and Development

- Independent creation, consolidation, and quality control of registration dossiers, including eCTD submissions, variations, and renewals

- Evaluation of regulatory requirements and development of registration strategies in the field of Chemistry, Manufacturing, and Controls (CMC)

- Handling complex national and international regulatory inquiries and preparing well-founded responses and scientific-regulatory justifications

- Monitoring of regulatory developments and evaluation of their impact on existing registrations and ongoing projects

- Leading and participating in projects to optimize regulatory processes, documentation standards, data governance, and eCTD compliance

- Providing expert advice to internal stakeholders on regulatory and CMC-related issues and supporting inspections and audits

Profile

- Completed degree in a natural science, e.g., chemical engineering, chemistry, or a related field B. Pharmacy, Chemistry, Biology or Biotechnology; PhD preferred

- Several years of professional experience in Regulatory Affairs CMC, Pharmaceutical Affairs or a comparable role in the pharmaceutical or GxP-regulated environment

- Sound knowledge of regulatory requirements (EU, national authorities, ICH) and experience with CTD/eCTD dossiers

- Proven experience in the preparation and evaluation of CMC documentation for CTD modules 2.3 and 3 as well as in variations, renewals and lifecycle management

- Proficient use of regulatory document management and publishing systems, e.g., eCTD Manager

- Strong analytical skills and high competence in evaluating complex pharmaceutical and regulatory issues

- Fluent German and English, both written and spoken

- Independent, structured, and solution-oriented work style, as well as strong communication and stakeholder management skills

The offer

- Diverse and varied topics in a modern, multicultural work environment

- Flexible working hours and the option to work remotely

- Company pension: 100% employer-funded retirement plan

- Company health insurance: Annual budget of €900, e.g., for vision aids, dental care

- Secure job in an attractive, growing pharmaceutical company

Content: © Federal Employment Agency − Reference number: 12634-BB-645266-7878-3412-S